Major local drug makers Aurobindo Pharma and Sun Pharmaceutical Industries are recalling various products from the US market due to deviation from standard manufacturing standards.
According to the latest enforcement report published by the United States Food and Drug Administration (USFDA), the United States branch of Aurobindo Pharma is recalling 1,15,776 vials of moxifloxacin ophthalmic solution, an antibiotic used in the treatment of bacterial infections.
According to the USFDA, Princeton-based Aurobindo Pharma USA Inc is recalling the affected lot due to “non-compliant impurity/degradation specifications.”
The company launched the nationwide Class II recall on January 14 this year.
The USFDA said the US branch of Sun Pharma was recalling 59,232 bottles of chlorthalidone tablets, used to reduce excessive fluid levels in the body.
According to US health regulator, New Jersey-based Sun Pharma Inc is recalling the affected lot due to “foreign material identified as microscopic stainless steel wear particles mixed with punch lubricating oil and silicone particles from the dust cup”.
The company initiated the Class II voluntary recall on February 7, 2022.
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an offending product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences health is low.
According to industry estimates, the US generic drug market was estimated at around $115.2 billion in 2019.
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